Solar LS Cjsc

Solar LS CJSC specializes in medical laser systems, including the Incanto, Evoline Platinum, and Evoline models. These devices are primarily used for dermatological and cosmetic treatments such as hair removal, skin resurfacing, and tattoo removal. Their design leverages advanced laser technology to deliver precise and effective results for these procedures.

Solar LS CJSC is headquartered in the United States. The company’s location in the US influences its regulatory compliance, including how its devices are classified and authorized for market distribution.

Solar LS CJSC’s medical laser systems fall under Class II classification in the US. This classification is determined by the FDA based on the device’s intended use and risk level, requiring compliance with specific regulatory controls, including premarket notifications (510(k)) to demonstrate substantial equivalence to legally marketed predicate devices.

Solar LS CJSC’s devices are listed in the FDA 510(k) registry, which tracks premarket notifications for Class II medical devices. This registry confirms that the devices have undergone the required FDA review process to demonstrate compliance with regulatory standards before commercial distribution in the US.